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Alternative Methods
Validated methods
•
ELISA test for batch potency testing of erysipelas vaccines
Date of the ESAC statement: 28 June 2002
Links:
ESAC Statement
[PDF]
•
Embryonic stem cell test for embryotoxicity
Date of the ESAC statement: 01 May 2002
Links:
INVITTOX Protocol,
ESAC Statement
[PDF]
•
Micromass embryotoxicity assay
Date of the ESAC statement: 01 May 2002
Links:
INVITTOX Protocol,
ESAC Statement
[PDF]
•
Whole rat embryo embryotoxicity assay
Date of the ESAC statement: 01 May 2002
Links:
INVITTOX Protocol,
ESAC Statement
[PDF]
•
CORROSITEX assay for skin corrosivity
Date of the ESAC statement: 06 December 2000
Remarks: The ESAC statement is based on the outcome of the US NTP-NICEATM
study.
Links:
INVITTOX Protocol,
ESAC Statement
[PDF]
•
ELISA test for batch potency testing of tetanus vaccines for human use
Date of the ESAC statement: 06 December 2000
Links:
ESAC Statement
[PDF]
•
Toxin Binding Inhibition (ToBI) test for batch potency testing of tetanus
vaccines for human use
Date of the ESAC statement: 06 December 2000
Links:
ESAC Statement
[PDF]
•
Local Lymph Node Assay for skin sensitisation (LLNA)
Date of the ESAC statement: 21 March 1999
Remarks: The ESAC statement is based on a retrospective data analysis.
Links:
ESAC Statement
[PDF]
•
3T3 Neutral Red Uptake (NRU) phototoxicity test
Date of the ESAC statement: 20 May 1998, 03 November 1997
Links:
INVITTOX Protocol,
ESAC Statement
[PDF]
• In
vitro production of monoclonal antibodies
Date of the ESAC statement: 14 May 1998
Remarks: The ESAC statement is based on a retrospective data analysis.
Links:
ESAC Statement
[PDF]
•
EpiSkinTM skin corrosivity test
Date of the ESAC statement: 03 April 1998
Links:
INVITTOX Protocol,
ESAC Statement
[PDF]
•
Rat Transcutaneous Electrical Resistance (TER) skin corrosivity test
Date of the ESAC statement: 03 April 1998
Links:
INVITTOX Protocol,
ESAC Statement
[PDF]
•
EpiDermTM skin corrosivity test
Date of the ESAC statement: 21 March 1998
Links:
INVITTOX Protocol,
ESAC Statement
[PDF]
Accepted into regulations
•
EpiSkinTM skin corrosivity test
Regulation: included into Annex V of Council Directive 67/548/EEC part B.40
on skin corrosion in April 2000; and Draft OECD Test Guideline 431 approved
in May 2002.
Links:
67/548/EEC,
OECD
[PDF]
•
3T3 NRU phototoxicity test
Regulation: included into Annex V of Council Directive 67/548/EEC part B.41
on phototoxicity in April 2000; and Draft OECD Test Guideline 432, approved
in May 2002.
Links:
67/548/EEC,
OECD
[PDF]
•
EpiDermTM skin corrosivity test
Regulation: included into Annex V of Council Directive 67/548/EEC part B.40
on skin corrosion in April 2000; and Draft OECD Test Guideline 431 approved
in May 2002.
Links:
67/548/EEC,
OECD
[PDF]
•
Rat TER skin corrosivity test
Regulation: included into Annex V of Council Directive 67/548/EEC part B.40
on skin corrosion in April 2000; and Draft OECD Test Guideline 430 approved
in May 2002.
Links:
67/548/EEC,
OECD
[PDF]
• In
vitro tests for percutaneous absorption
Regulation: Draft OECD Test Guideline 428 approved in May 2002
Links:
OECD
[PDF]
• Deletion of the acute oral toxicity
test, Lethal Dose (LD50)
Regulation: the method has been deleted in 2001 from both the Annex V of
Council Directive 67/548/EEC (Method B.1.), as well as from the OECD Test
Guidelines (TG 401).
Links:
67/548/EEC,
OECD
•
Local Lymph Node Assay for skin sensitisation (LLNA)
Regulation: Updated OECD Test Guideline 429, adopted 24 April 2002; and U.S.
EPA - OPPTS Harmonized Test Guideleine 870.2600 on Skin Sensitization,
August 1998
Links:
OECD,
U.S. EPA OPPTS
•
ELISA test for batch potency testing of erysipelas vaccines
Regulation: The method has been included in the monograph on swine
erysipelas vaccine (European Pharmacopoeia, 4.6; No 01/2004:0064)
Links:
EDQM/European Pharmacopoeia
•
ELISA test for batch potency testing of tetanus vaccines for human use
Regulation: The method has been included in the general text 2.7.8 Assay of
tetanus vaccine (adsorbed) and adopted by the European Pharmacopoeia
Commission in March 2003.
Links:
EDQM/European Pharmacopoeia
•
Toxin Binding Inhibition (ToBI) test for batch potency testing of tetanus
vaccines for human use
Regulation: The method has been included in the general text 2.7.8 Assay of
tetanus vaccine (adsorbed) and adopted by the European Pharmacopoeia
Commission in March 2003.
Links:
EDQM/European Pharmacopoeia
Recommended to remove from the regulations
•
The batch potency testing of erythropoietin concentrated solution
Date of the ESAC statement: 28 June 2002
•
The relevance of the target-animal safety test for batch safety testing of
vaccines for veterinary use
Date of the ESAC statement: 28 June 2002
Remarks: The ESAC statement is based on a retrospective data
analysis.
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